Nicergoline, pills 10mg 30pcs

Composition

1 tablet contains:

Active ingredient:

nicergoline – 10 mg

Excipients

lactose monohydrate-70.0 mg

potato starch-26.9 mg

colloidal silicon dioxide (aerosil) – 2.0 mg

magnesium stearate-1.1 mg

The average weight of a tablet without a shell is 110 mg

Excipients for the shell

sucrose (sugar) – 65.3 mg

povidone-1.967 mg

magnesium hydroxycarbonate pentahydrate-2.1 mg

colloidal silicon dioxide (aerosil) – 0.13 mg

talc-0.016 mg

titanium dioxide-0.37 mg

beeswax-0.117 mg

The average weight of a coated tablet is 180 mg

Excipients-the core:

potato starch,

magnesium carbonate basic,

milk sugar (lactose),

stearic acid,

magnesium stearate,

polyvinylpyrrolidone low molecular weight medical (povidone),

shell:

sucrose,

basic magnesium carbonate,

aerosil (colloidal silicon dioxide),

low molecular weight medical polyvinylpyrrolidone (povidone),

talc,

beeswax,

medical gelatin,

titanium dioxide.

Pharmacological action

Pharmacotherapeutic group

Alpha-adrenoblocker

Pharmacological properties Exhibits alpha-1-adrenoblocking effect

Pharmacokinetics

After oral use, nicergoline is rapidly and almost completely absorbed. The main products of nicergoline metabolism are 1,6-dimethyl-8β-hydroxymethyl-10α-methoxyergoline (MMDL, a product of hydrolysis) and 6-methyl-8β-hydroxymethyl-10α-methoxyergoline (MDL, a product of demethylation under the action of the CYP2D6 isoenzyme). The ratios of the area values under the concentration-time curve (AUC) for MMDL and MDL with oral and intravenous use of nicergoline indicate a pronounced metabolism at the first pass. After oral use of 30 mg of nicergoline, the maximum concentrations of MMDL (21 ± 14 ng / ml) and MDL (41 ± 14 ng/ml) were reached after approximately 1 and 4 hours, respectively, then the concentration of MDL decreases with a half-life of 13-20 hours. Food intake does not significantly affect the degree and rate of absorption of nicerglin.

Nicergoline binds actively (> 90%) to plasma proteins, and the degree of its affinity for alpha-acid glycoprotein is greater than for serum albumin. It has been shown that nicergoline and its metabolites can be distributed in blood cells. The pharmacokinetics of nicergoline at doses up to 60 mg are linear and do not change depending on the patient’s age.

Nicergoline is excreted in the form of metabolites, mainly in the urine (approximately 80% of the total dose) and in small amounts in the faeces (10-20%). In patients with severe renal insufficiency, there is a significant decrease in the degree of excretion of metabolic products in the urine compared to patients with normal renal function.

Indications

Acute and chronic cerebral metabolic and vascular disorders (due to atherosclerosis, arterial hypertension, thrombosis or embolism of cerebral vessels), including transient ischemic attack, vascular dementia and headache caused by vasospasm.

Acute and chronic (metabolic and vascular) peripheral disorders (organic and functional arteriopathies, Raynaud’s disease, syndromes caused by impaired peripheral blood flow).

Use during pregnancy and lactation

Nicergoline should only be used if the expected benefit to the mother exceeds the possible risk to the fetus and child.

Contraindications

Hypersensitivity to nicergoline or other components of the drug, recent myocardial infarction, acute bleeding, severe bradycardia, orthostatic regulation disorder, sucrose/isomaltase deficiency, lactase deficiency, lactose intolerance, fructose intolerance, glucose-galactose malabsorption, children under 18 years of age.

With caution

Hyperuricemia or gout in the anamnesis and / or in combination with medications that interfere with the metabolism or excretion of uric acid.

Side effects

Allergic reactions, low blood pressure, dizziness, feeling hot, drowsiness or insomnia, dyspeptic phenomena.

It is possible to increase the concentration of uric acid in the blood, and this effect does not depend on the dose and duration of therapy. The side effect is usually mild to moderate.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Increases the effects of antihypertensive medications. nicergoline is metabolized by the CYP450 2D6 isoenzyme, so the possibility of its interaction with drugs that are metabolized with the participation of the same enzyme cannot be excluded.

How to take, course of use and dosage

Inside,10 mg three times a day with the same intervals between doses for a long period of time (up to several months).

For vascular dementia, the use of 30 mg 2 times a day is indicated, and every 6 months it is recommended to consult a doctor about the feasibility of continuing therapy.

The dose and duration of treatment depend on the nature, severity of the disease and the effectiveness of the treatment. In some cases, it is preferable to start therapy with parenteral use, and then switch to oral use for maintenance treatment.

In patients with impaired renal function (serum creatinine ≥ 2 mg/dl), the drug is recommended to be used in lower therapeutic doses.

Overdose

Symptoms:  transient marked decrease in blood pressure.

Treatment:  special treatment is usually not required, it is enough to put the patient in a horizontal position for a few minutes, in exceptional cases, with a sharp violation of the blood supply to the brain and heart, the introduction of sympathomimetic agents under constant monitoring of blood pressure is recommended.

Special instructions

In therapeutic doses, nicergoline, as a rule, does not affect blood pressure, however, in patients with arterial hypertension, the drug can cause a gradual decrease in blood pressure.

The drug works gradually, so it should be taken for a long time, and the doctor should periodically (at least every 6 months) evaluate the effect of continuing treatment.

Influence on the ability to drive vehicles and maintain moving mechanisms

Despite the fact that nicergoline improves reaction time and concentration, its effects on the ability to drive a car and use complex equipment have not been specifically studied. In any case, caution should be exercised, given the nature of the underlying disease.

Form of production

Tablets coated with a white color, round, biconvex shape.

The cross section shows two layers

Storage conditions

In a place protected from light, at a temperature not exceeding 20 °C.

Shelf life

3 years

Active ingredient

Nicergoline

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Vascular Eye Diseases, Raynaud’s Disease, Acquired Dementia, Cerebral Circulatory Disorders